BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 7110541 · Received December 12, 2017

    Report

    Report Number
    2916596-2017-03126
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 15, 2017
    Report Date
    April 24, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DIRECT CORRELATION BETWEEN THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS INVESTIGATION. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    SHAH, KEYUR B.; GUNDA, SAMPATH; EMANI, SITARAMESH; KANWAR, MANREET K.; URIEL, NIR; COLOMBO, PAOLO C.; UBER, PATRICIA A.; SEARS, MELISSA L.; CHUANG, JOYCE; FARRAR, DAVID J.; BROPHY, DONALD F.; SMALLFIELD, GEORGE B. CIRCULATION: HEART FAILURE, USA, 2017, VOL 10 (ISSUE 11) P.E004500, STATING: ¿MULTICENTER EVALUATION OF OCTREOTIDE AS SECONDARY PROPHYLAXIS IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES AND GASTROINTESTINAL BLEEDING¿ SECTION A2, A3, A4, D4, D6, F9, H4: THE LITERATURE CONSISTED OF 51 PATIENTS; THEREFORE, THE SPECIFIC DEVICE AND OTHER CASE/PATIENT INFORMATION IS NOT AVAILABLE, AND WAS NOT REQUESTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS NOTED DURING A JOURNAL ARTICLE REVIEW. GASTROINTESTINAL (GI) BLEEDING IS A FREQUENT COMPLICATION AFTER CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION. FIFTY-ONE PATIENTS AT THE 5 CENTERS ((B)(6)) WERE IDENTIFIED TO HAVE EXPERIENCED A GI BLEED FROM 2009 TO 2015, 41% (21 PATIENTS) HAD EXPERIENCED A PRIOR GI BLEED ON THE DEVICE. TWELVE OF THE 51 SUBJECTS (24%) IN THIS STUDY EXPERIENCED A REBLEED WITHIN 6 MONTHS OF BEGINNING OCTREOTIDE TREATMENT. SOURCES OF BLEEDING (CAN BE MULTIPLE) WERE ANGIODYSPLASIA, BASCULAR BLEEDING, BLEEDING POLYP, ULCER/MUCOSAL DISRUPTION, OTHER, AND SOURCE NOT LOCATED. THE CLINICAL INTERVENTIONS PERFORMED IN THE OCTREOTIDE TREATED GROUP WERE BLOOD PRODUCTS, ENDOSCOPY, REDUCTION IN ASPIRIN AND WARFARIN DOSE, REDUCTION IN LVAD SPEED. PRIOR LVAD-RELATED COMPLICATIONS WERE ALSO IDENTIFIED, 6 PATIENTS HAD SUPERFICIAL DRIVELINE INFECTION, 2 PATIENTS PUMP INFECTION, 15 PATIENTS HAD BACTEREMIA, 7 PATIENTS HAD PUMP THROMBOSIS, 5 PATIENTS ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA), 1 PATIENT HAD HEMORRHAGIC CVA, 3 PATIENTS HAD PERIPHERAL ARTERIAL EMBOLIC EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DATE OF OCCURRENCE IS ENTERED AS THE DATE OF PUBLICATION. THE LITERATURE CONSISTED OF 51 PATIENTS; THEREFORE, THE SPECIFIC DEVICE AND OTHER CASE/PATIENT INFORMATION IS NOT AVAILABLE, AND WAS NOT REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888636 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention